Short answer: during a June 2025 inspection, an FDA investigator watched staff at Yuyao City Boss Vegetable Factory Co. Ltd. in Zhejiang, China, create and backdate pH and process records for acidified mustard stems sold in pouches. FDA placed the firm's pickled mustard stem products on Import Alert 99-38 on October 23, 2025 and issued a warning letter on November 28, 2025.
This article summarizes a public FDA warning letter and import-alert entry. The company named in those records is not identified as an FDABridge client, and neither record reports illnesses or a recall.
What happened at the Chinese acidified vegetable plant?
FDA inspected the facility in Yuyao, Ningbo, on June 16 and 17, 2025. According to the warning letter, no processing or production records showing adherence to the critical factors in the firm's filed scheduled processes were available for retail pouches of acidified mustard stems shipped to the United States between April 28, 2024 and June 9, 2025.
On the first morning, after a three-hour walk-through, the investigator saw the quality control manager and an administrative staff member creating and backdating records, including finished-product pH results, daily production logs, batching records, water-bath monitoring records and critical-factor monitoring records. FDA states that the firm admitted that production records documenting critical-factor monitoring were being fabricated during the walk-through, and that the backdated records covered mustard stems made since 2023. At the close of the inspection, the investigator explained that records must be “true, accurate, and completed at the time the activity is performed.”
Why did FDA act on records instead of a test result?
Under 21 CFR 114.3, acidified foods are low-acid foods with added acids or acid foods, a water activity above 0.85 and a finished equilibrium pH of 4.6 or below. Their safety depends on the scheduled process, which includes control of pH and other critical factors and is selected so that the food will not permit the growth of microorganisms of public health significance.
Under 21 CFR 114.100(b), processing and production records must show adherence to the scheduled process, including pH and other critical factors, with enough detail to permit a public health hazard evaluation of each lot. Records written after the fact cannot do that. FDA concluded that the firm could not show its mustard stems were made according to its filed processes and that the products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. For foreign processors, 21 CFR 108.25(j) replaces the emergency permit route with refusal of admission.
The firm's July 4, 2025 response described a new risk assessment, retraining and a record-review system but included only one example of each document, so FDA could not evaluate long-term critical-factor monitoring. A pH record in the response also appeared to accept a result that, according to FDA, did not match the filed process.
Import Alert 99-38 lists all varieties of the firm's ready-to-eat acidified pickled mustard stems in foil pouches. To leave its Red List, a firm needs to give FDA information showing that it has resolved the conditions behind the violation, for example records proving manufacture under the scheduled process, a recognized process authority's evaluation, heat penetration data or third-party certification, provided in English.
What should the processor have had in place?
A filed scheduled process is a commitment that FDA can audit. Under 21 CFR 108.25(c), a foreign acidified-food processor must register before offering foods for import and file its scheduled processes. Filing is not FDA approval, and each food must be processed in conformity with at least the filed process. Import Alert 99-38 applies only where a firm has already treated its product as a low-acid canned or acidified food by submitting a scheduled process, so filing brought this firm into the system without shielding it from a records review.
Part 114 also sets the daily controls: operating supervision by a person who has completed the course required by 21 CFR 114.10, pH testing and recording frequent enough to keep the finished equilibrium pH at or below 4.6, container codes identifying the establishment, product and packing period, and a separate file for process deviations. Under 21 CFR 108.25(g), processing, deviation and pH records must be prepared, reviewed and kept for three years, and FDA may inspect and copy them on written demand during an inspection.
A records checklist for acidified food exporters
- Match the work instructions on the line to each filed scheduled process, by product and container size.
- Record pH and other critical factors when the activity happens, by the person who performs or observes it, and never complete or backdate a record later.
- Set finished-product pH acceptance criteria that match the filed process, and log any departure as a deviation.
- Confirm before shipment that every US-bound lot code traces to its production, pH and processing records.
- When answering FDA, send evidence from multiple lots. FDA asked this firm for processing records covering at least five lots produced over at least five days.
Related guidance
Classification and filing duties for acidified and low-acid canned foods are explained in the FCE/SID registration guide for low-acid and acidified canned foods. How import alerts and removal requests work is covered in what an FDA import alert is and how facilities get removed, and warning-letter responses in how foreign facilities should respond to FDA warning letters. Inspection preparation is discussed in FDA inspections of foreign registered facilities.
How FDABridge helps
FDABridge's FCE/SID registration service assesses product, formulation, container and US-market scope, prepares the Food Canning Establishment registration where required and prepares scheduled-process filings from qualified process data supplied by the processor and its process authority. As that page states, scientific process development and production controls remain separate responsibilities, so a filing cannot replace lot records. Food facility registration, including first-year U.S. agent coverage for foreign facilities, is a separate service. Neither filing is FDA approval.
Sources: FDA warning letter to Yuyao City Boss Vegetable Factory Co. Ltd., MARCS-CMS 717174, November 28, 2025 (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yuyao-city-boss-vegetable-factory-co-ltd-717174-11282025); FDA Import Alert 99-38 (https://www.accessdata.fda.gov/cms_ia/importalert_1132.html); 21 CFR 108.25 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-108/subpart-B/section-108.25); 21 CFR Part 114 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114).